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Description of key information

The primary skin irritation potential of the test item was investigated according to ISO 10993 -10:2010. The test item (0.5 g wetted with tap water) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for 24 hours (one patch with test material on each side of the vertebral column). The scoring of the skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. The mean score of the 24, 48 and 72 h readings from two patches was calculated for each animal. No edema was observed at any time point (score 0) and only very slight erythema were seen in two animals (score 1) which were reversible after 72 hours at the latest. There was no indication of systemic toxicity.

The test material was subject to an acute eye irritation / corrosion test in the rabbit according to OECD TG 405.The test item was applied by instillation of 0.1 ml (0.05 g) into the conjunctival sac of the right eye of each of three New Zealand White rabbits. The scoring of irritating effects was performed 1, 24, 48 and 72 hours after test item instillation.No iridial effects were noted during the study. Very slight corneal opacity (score 1) was observed in one animal 24 hours after test substance application but not in the two other test animals at any timepoint. Conjunctival redness (score 1 or 2) was observed in every animal one and 24 h after application, and in one animals still at the 48 h reading, but fully reversible by 72 h after application. Chemosis (score 1) was observed in every animal one hour after application but not at later time points.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From19 MAY 2011 to 20 JUN 2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines/standards
Qualifier:
according to guideline
Guideline:
other: ISO 10993-10:2010
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:DNA Rabbitry, Elk River, MN, CANADA
- Age at study initiation: young adults
- Weight at study initiation: 2.2 to 2.3 kg
- Housing: individually housed in suspended stainless steel caging
- Diet: certified commercial animal feed
- Water: potable water from the St. Paul municipal water supply
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- environmental conditions in the animal rooms were maintained according to WuXiAppTec SOP:ILS-0018. The temperature and photoperiod were set to meed the Assessment and Accreditation of Laboratory Animal Care (AAALAC) International recommendations for these species
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 x 0.5 g/animal (i.e.: 0.5 g/patch) wetted with tap water

Duration of treatment / exposure:
24 h
Observation period:
1, 24, 48 and 72 h after end of exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 1x1 inch, one patch with test material and one control patch was applied on each side of the vertebral column, i.e. two patches with test material were applied to each animals back
- Type of wrap if used: elastic bandage and hypoallergenic tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with diluted alcohol, slightly swab
- Time after start of exposure: 24 hours (directly after unwrapping )

SCORING SYSTEM: erythema and edema scoring according to Draize system (cf OECD 404)

CALCULATION OF MEAN SCORES: the mean of the 24, 48 and 72 h readings from two patches (i.e. mean of 6 readings / animal) was calculated for each animal
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: animal treated at two sides
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: animal treated at two sides
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable since no effects
Remarks on result:
other: animal treated at two sides
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable since no effects
Remarks on result:
other: animals treated at two sides
Irritant / corrosive response data:
Animal #1 showed a very slight erythema (score = 1) 24 hours after patch removal on the right side of the back, which was gone at the 48 hours reading. At the 48 Hour reading there was a very slight erythema on the left side, which was gone at the 72 hour reading.
Animal #2 showed a very slight erythema 24 hours after patch removal on one side of the back (Score = 1), which was gone at the 48 h reading.
Animal #3 showed no reaction at any reading (erythema and edema score 0).

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the applied test conditions the tes titem did not show any remarkable irritation potential onto the skin of rabbits.
Executive summary:
The primary skin irritation potential of the test item was investigated according to ISO 10993 -10:2010. The test item (0.5 g wetted with tap water) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for 24 hours (one patch with test material on each side of the vertebral column). The scoring of the skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. The mean score of the 24, 48 and 72 h readings from two patches was calculated for each animal. No edema was observed at any time point (score 0) and only very slight erythema were seen in two animals (score 1) which were reversible after 72 hours at the latest. There was no indication of systemic toxicity.
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From19 MAY 2011 to 20 JUN 2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines/standards
Justification for type of information:
See read across document in chapter13
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: ISO 10993-10:2010
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:DNA Rabbitry, Elk River, MN, CANADA
- Age at study initiation: young adults
- Weight at study initiation: 2.2 to 2.3 kg
- Housing: individually housed in suspended stainless steel caging
- Diet: certified commercial animal feed
- Water: potable water from the St. Paul municipal water supply
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- environmental conditions in the animal rooms were maintained according to WuXiAppTec SOP:ILS-0018. The temperature and photoperiod were set to meed the Assessment and Accreditation of Laboratory Animal Care (AAALAC) International recommendations for these species
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 x 0.5 g/animal (i.e.: 0.5 g/patch) wetted with tap water

Duration of treatment / exposure:
24 h
Observation period:
1, 24, 48 and 72 h after end of exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 1x1 inch, one patch with test material and one control patch was applied on each side of the vertebral column, i.e. two patches with test material were applied to each animals back
- Type of wrap if used: elastic bandage and hypoallergenic tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with diluted alcohol, slightly swab
- Time after start of exposure: 24 hours (directly after unwrapping )

SCORING SYSTEM: erythema and edema scoring according to Draize system (cf OECD 404)

CALCULATION OF MEAN SCORES: the mean of the 24, 48 and 72 h readings from two patches (i.e. mean of 6 readings / animal) was calculated for each animal
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: animal treated at two sides
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: animal treated at two sides
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable since no effects
Remarks on result:
other: animal treated at two sides
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable since no effects
Remarks on result:
other: animals treated at two sides
Irritant / corrosive response data:
Animal #1 showed a very slight erythema (score = 1) 24 hours after patch removal on the right side of the back, which was gone at the 48 hours reading. At the 48 Hour reading there was a very slight erythema on the left side, which was gone at the 72 hour reading.
Animal #2 showed a very slight erythema 24 hours after patch removal on one side of the back (Score = 1), which was gone at the 48 h reading.
Animal #3 showed no reaction at any reading (erythema and edema score 0).

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the applied test conditions the tes titem did not show any remarkable irritation potential onto the skin of rabbits.
Executive summary:

The primary skin irritation potential of the test item was investigated according to ISO 10993 -10:2010. The test item (0.5 g wetted with tap water) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for 24 hours (one patch with test material on each side of the vertebral column). The scoring of the skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. The mean score of the 24, 48 and 72 h readings from two patches was calculated for each animal. No edema was observed at any time point (score 0) and only very slight erythema were seen in two animals (score 1) which were reversible after 72 hours at the latest. There was no indication of systemic toxicity.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From19 MAY 2011 to 20 JUN 2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines/standards
Justification for type of information:
See read across document in chapter13
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: ISO 10993-10:2010
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:DNA Rabbitry, Elk River, MN, CANADA
- Age at study initiation: young adults
- Weight at study initiation: 2.2 to 2.3 kg
- Housing: individually housed in suspended stainless steel caging
- Diet: certified commercial animal feed
- Water: potable water from the St. Paul municipal water supply
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- environmental conditions in the animal rooms were maintained according to WuXiAppTec SOP:ILS-0018. The temperature and photoperiod were set to meed the Assessment and Accreditation of Laboratory Animal Care (AAALAC) International recommendations for these species
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 x 0.5 g/animal (i.e.: 0.5 g/patch) wetted with tap water

Duration of treatment / exposure:
24 h
Observation period:
1, 24, 48 and 72 h after end of exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 1x1 inch, one patch with test material and one control patch was applied on each side of the vertebral column, i.e. two patches with test material were applied to each animals back
- Type of wrap if used: elastic bandage and hypoallergenic tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with diluted alcohol, slightly swab
- Time after start of exposure: 24 hours (directly after unwrapping )

SCORING SYSTEM: erythema and edema scoring according to Draize system (cf OECD 404)

CALCULATION OF MEAN SCORES: the mean of the 24, 48 and 72 h readings from two patches (i.e. mean of 6 readings / animal) was calculated for each animal
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: animal treated at two sides
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: animal treated at two sides
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable since no effects
Remarks on result:
other: animal treated at two sides
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable since no effects
Remarks on result:
other: animals treated at two sides
Irritant / corrosive response data:
Animal #1 showed a very slight erythema (score = 1) 24 hours after patch removal on the right side of the back, which was gone at the 48 hours reading. At the 48 Hour reading there was a very slight erythema on the left side, which was gone at the 72 hour reading.
Animal #2 showed a very slight erythema 24 hours after patch removal on one side of the back (Score = 1), which was gone at the 48 h reading.
Animal #3 showed no reaction at any reading (erythema and edema score 0).

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the applied test conditions the tes titem did not show any remarkable irritation potential onto the skin of rabbits.
Executive summary:

The primary skin irritation potential of the test item was investigated according to ISO 10993 -10:2010. The test item (0.5 g wetted with tap water) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for 24 hours (one patch with test material on each side of the vertebral column). The scoring of the skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. The mean score of the 24, 48 and 72 h readings from two patches was calculated for each animal. No edema was observed at any time point (score 0) and only very slight erythema were seen in two animals (score 1) which were reversible after 72 hours at the latest. There was no indication of systemic toxicity.

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 25 MAY 2011 to 16 Jun 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 405) and GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Robinson Services, Inc
- Age at study initiation: young adult
- Housing: single in suspended stainless steel cages
- Diet: Harlan Teklad Global High Fiber Rabbit Diet 2031
- Water: Filtered tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 63-83%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (0.05 g)
Duration of treatment / exposure:
72 h (single application, the treated eyes were not rinsed after application)
Observation period (in vivo):
72 h with observation time points at 1, 24, 48 and 72 h.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: high-intensity white light (Mag Lite), fluorescein (at 24 and/or 48 h reading)
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #3 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effect
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritant / corrosive response data:
Individual Animal data (time points: 1h / 24h / 48h / 72h after application, animal #1, animal#2 animal #3)

cornea: 0/0/0/0, 0/1/0/0, 0/0/0/0
iris: 0/0/0/0, 0/0/0/0, 0/0/0/0
conjunctivae redness: 2/1/0/0, 2/2/0/0, 2/2/1/0
chemosis: 1/0/0/0, 1/0/0/0, 1/0/0/0
Other effects:
no signs of gross toxicity or behavioral changes.
Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test item did not reveal any remarkable irritation potential on the eyes of rabbits, tested in this study according to OECD test guideline no. 405 and GLP conditions.
Executive summary:

The test material was subject to an acute eye irritation / corrosion test in the rabbit according to OECD TG 405. The test item was applied by instillation of 0.1 ml (0.05 g) into the conjunctival sac of the right eye of each of three New Zealand White rabbits. The scoring of irritating effects was performed 1, 24, 48 and 72 hours after test item instillation. No iridial effects were noted during the study. Very slight corneal opacity (score 1) was observed in one animal 24 hours after test substance application but not in the two other test animals at any timepoint. Conjunctival redness (score 1 or 2) was observed in every animal one and 24 h after application, and in one animals still at the 48 h reading, but fully reversible by 72 h after application. Chemosis (score 1) was observed in every animal one hour after application but not at later time points.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From 25 MAY 2011 to 16 Jun 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 405) and GLP
Justification for type of information:
See read across document in chapter 13
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Robinson Services, Inc
- Age at study initiation: young adult
- Housing: single in suspended stainless steel cages
- Diet: Harlan Teklad Global High Fiber Rabbit Diet 2031
- Water: Filtered tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 63-83%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (0.05 g)
Duration of treatment / exposure:
72 h (single application, the treated eyes were not rinsed after application)
Observation period (in vivo):
72 h with observation time points at 1, 24, 48 and 72 h.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: high-intensity white light (Mag Lite), fluorescein (at 24 and/or 48 h reading)
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #3 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effect
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritant / corrosive response data:
Individual Animal data (time points: 1h / 24h / 48h / 72h after application, animal #1, animal#2 animal #3)

cornea: 0/0/0/0, 0/1/0/0, 0/0/0/0
iris: 0/0/0/0, 0/0/0/0, 0/0/0/0
conjunctivae redness: 2/1/0/0, 2/2/0/0, 2/2/1/0
chemosis: 1/0/0/0, 1/0/0/0, 1/0/0/0
Other effects:
no signs of gross toxicity or behavioral changes.
Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test item did not reveal any remarkable irritation potential on the eyes of rabbits, tested in this study according to OECD test guideline no. 405 and GLP conditions.
Executive summary:

The test material was subject to an acute eye irritation / corrosion test in the rabbit according to OECD TG 405. The test item was applied by instillation of 0.1 ml (0.05 g) into the conjunctival sac of the right eye of each of three New Zealand White rabbits. The scoring of irritating effects was performed 1, 24, 48 and 72 hours after test item instillation. No iridial effects were noted during the study. Very slight corneal opacity (score 1) was observed in one animal 24 hours after test substance application but not in the two other test animals at any timepoint. Conjunctival redness (score 1 or 2) was observed in every animal one and 24 h after application, and in one animals still at the 48 h reading, but fully reversible by 72 h after application. Chemosis (score 1) was observed in every animal one hour after application but not at later time points.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From 25 MAY 2011 to 16 Jun 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 405) and GLP
Justification for type of information:
See read across document in chapter 13
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Robinson Services, Inc
- Age at study initiation: young adult
- Housing: single in suspended stainless steel cages
- Diet: Harlan Teklad Global High Fiber Rabbit Diet 2031
- Water: Filtered tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 63-83%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (0.05 g)
Duration of treatment / exposure:
72 h (single application, the treated eyes were not rinsed after application)
Observation period (in vivo):
72 h with observation time points at 1, 24, 48 and 72 h.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: high-intensity white light (Mag Lite), fluorescein (at 24 and/or 48 h reading)
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #3 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effect
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritant / corrosive response data:
Individual Animal data (time points: 1h / 24h / 48h / 72h after application, animal #1, animal#2 animal #3)

cornea: 0/0/0/0, 0/1/0/0, 0/0/0/0
iris: 0/0/0/0, 0/0/0/0, 0/0/0/0
conjunctivae redness: 2/1/0/0, 2/2/0/0, 2/2/1/0
chemosis: 1/0/0/0, 1/0/0/0, 1/0/0/0
Other effects:
no signs of gross toxicity or behavioral changes.
Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test item did not reveal any remarkable irritation potential on the eyes of rabbits, tested in this study according to OECD test guideline no. 405 and GLP conditions.
Executive summary:

The test material was subject to an acute eye irritation / corrosion test in the rabbit according to OECD TG 405. The test item was applied by instillation of 0.1 ml (0.05 g) into the conjunctival sac of the right eye of each of three New Zealand White rabbits. The scoring of irritating effects was performed 1, 24, 48 and 72 hours after test item instillation. No iridial effects were noted during the study. Very slight corneal opacity (score 1) was observed in one animal 24 hours after test substance application but not in the two other test animals at any timepoint. Conjunctival redness (score 1 or 2) was observed in every animal one and 24 h after application, and in one animals still at the 48 h reading, but fully reversible by 72 h after application. Chemosis (score 1) was observed in every animal one hour after application but not at later time points.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

no classification

The test item did not cause irritating effects on skin or eyes in vivo.